Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) for Inoperable Non-small-cell Lung Cancer

NCT ID: NCT02841228

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-11-30

Brief Summary

Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Detailed Description

Lung cancer is one of the most common cancer and the leading causes of cancer death in patients worldwide. Approximately 80% of NSCLC were inoperable. Concurrent chemo-radiation therapy (CCRT) is a standard treatment for locally advanced NSCLC who are not candidates for surgery. Nevertheless, the prognosis of patients with locally advanced NSCLC (LA-NSCLC) is still poor. Local control (LC) after CCRT is one of the most important prognostic factors. Local failure is common after standard-dose chemoradiation for NSCLC. Studies of stereotactic body radiation therapy (SBRT) have shown a steep dose response in treating early-stage lung cancer. Improving the total dose and shortening the overall treatment time may be effective for improving the LC rates. However, problems remain due to the toxicity to adjacent critical structures (e.g,lung,heart, esophagus), the target volumes usually limits the doses escalated that cannot be safely delivered by conventional radiotherapy techniques. In order to avoid the acute and late radiation toxicity of normal tissues, different dose prescriptions can be delivered to different target volumes in the same fraction, which deliver a higher dose to the Gross Tumor Volume (GTV) and a relatively lower dose to the subclinical disease. The technique is called simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT).

Investigators hypothesized that use of SIB-IMRT technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT + SIB + Chemotherapy

For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction, SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

Group Type: EXPERIMENTAL

IMRT + SIB + Chemotherapy

Intervention Type: RADIATION

For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction , SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

Interventions

IMRT + SIB + Chemotherapy

For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction , SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th

2. Performance status 0 to 2, ≤5% weight loss within the past 6 months

3. A forced expiratory volume at 1 second of ≥ 1 L

4. Life expectancy > 3 months

5. No invasion of large vessels, heart, esophagus, spinal cord.

6. Based on conformal treatment planning, the volume of lung at or exceeding 20 Gy (V20) must have been≤30%, the mean esophagus dose≤34 Gy, and the volume of esophagus exceeding 55 Gy (V55)≤30%

7. Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy

8. Without severe other diseases

9. Informed consent

Exclusion Criteria

1. Had received prior thoracic radiotherapy

2. Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome

3. Pregnant and lactating women

4. Serious complications

5. Other primary malignancies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hui Wang

Chief of thoracic radiation oncology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hunan province tumor pospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

shengqi wu, M.D.

Role: primary

wushengqi@hnszlyy.com

13807316075

References

Yang W, Zeng B, Qiu Y, Tan J, Xu S, Cai Y, Zhou Y, Liu Z, Luo J, Wang H. A Dosimetric Comparison of Dose Escalation with Simultaneous Integrated Boost for Locally Advanced Non-Small-Cell Lung Cancer. Biomed Res Int. 2017;2017:9736362. doi: 10.1155/2017/9736362. Epub 2017 May 28.

Reference Type: DERIVED

PMID: 28630876 (View on PubMed)

Other Identifiers

SIB-IMRT

Identifier Type: -

Identifier Source: org_study_id